oral tablet split-dose regimens (45/15mg, 60/30 mg or 90/30 mg) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.

Other Name: OPC-41061 or OPC-156

Placebo Comparator: Placebo

Drug: Placebo

oral tablet split-dose regimens (45/15mg Placebo, 60/30 mg Placebo or 90/30 mg Placebo) by mouth twice a day on awakening and approximately 9 hours later for 36 months. Daily dose regimen based on maximally tolerated dose.

Detailed Description:

The current study will evaluate whether tolvaptan will be potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total renal volume increase, while impacting the onset, severity and progression of other important consequences of ADPKD.

Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods

In the opinion of the study investigator or sponsor may present a safety risk or confound study objectives

Patients who are unlikely to adequately comply with study procedures

Patients having contraindications to MRI

Patients taking medications or having any illnesses likely to affect ADPKD outcomes.

Contacts and Locations

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For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00428948